Abbott Announces Approval Of First Fully-Automated Blood Screening Test For Hepatitis C Antibodies

Main Category: Liver Disease / Hepatitis
Also Included In: Blood / Hematology;  Transplants / Organ Donations
Article Date: 13 Jul 2007 - 0:00 PDT

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Abbott (NYSE: ABT) announced today it received approval from the U.S. Food and Drug Administration for its ABBOTT PRISM(R) HCV test. This test can be used by laboratory technicians to screen individual donations of blood and plasma for antibodies to hepatitis C (HCV).

Used in more than 30 countries, the PRISM system was approved for use in the United States with its first three hepatitis B tests: a core hepatitis B test (PRISM(R) HBcore), introduced in October 2005; and two hepatitis B surface antigen tests (PRISM(R) HBsAg and HBsAg Confirmatory), introduced in July 2006. Additional retrovirus screening tests are currently under FDA review.

"With the ABBOTT PRISM system, we continue to support the infectious disease testing needs of the laboratory while helping them realize greater efficiencies and enhanced operator safety throughout the blood and plasma screening process," said William E. Brown III, Ph.D., vice president, diagnostic assays and systems development, Abbott. "The introduction of the PRISM HCV test reinforces Abbott's role as a leader in ensuring the safety of the world's blood supply."

In 1985, Abbott developed the first HIV blood-screening test approved in the United States. Abbott's hepatitis tests are used thousands of times every day around the globe for blood screening and diagnostic testing.

According to the American Association of Blood Banks (AABB), eight million volunteers donate about 15 million units of whole blood each year. Each donated unit of blood is tested for infectious diseases including hepatitis, HIV and other retroviruses.

Important Product Usage and Safety Information

The ABBOTT PRISM(R) HCV test [Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5)] can be used by laboratory technicians to screen individual donations of blood and plasma for antibodies to hepatitis C (HCV). This assay has not been validated for use with pooled specimens. The assay is not intended for use on cord blood specimens or for the laboratory diagnosis of HCV infection. This product contains human sourced and/or potentially infectious components.

About ABBOTT PRISM

The PRISM instrument consolidates testing into a single system automating many of the manual testing procedures and steps currently used to screen blood. Safety features built into the system help track and monitor each sample throughout the testing process providing documentation and quality control for testing facilities. The PRISM system can run 160 samples per hour, making it possible to test more than 1,200 samples per eight-hour shift.

About Abbott Diagnostics

Abbott Diagnostics is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics. With more than 69,000 institutional customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnostics from an art to a science through the company's commitment to improving patient care and lowering overall costs. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.

Abbott
http://www.abbott.com

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